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Andri Wardiana
Research Center for Biotechnology, Indonesian Institute of Sciences (LIPI)
Agriculture, Biological Sciences & Forestry Biochemistry, Genetics & Molecular Biology Chemical Engineering, Chemistry & Bioengineering Chemistry Immunology & microbiology Medicine & Pharmacology

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Roferon-A: A Biologic Product of Human Interferon Alpha 2a Andri Wardiana; Ratih Asmana Ningrum
ANNALES BOGORIENSES Vol 19, No 2 (2015): Annales Bogorienses
Publisher : Research Center for Biotechnology - Indonesian Institute of Sciences (LIPI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (423.11 KB) | DOI: 10.14203/ann.bogor.2015.v19.n2.1-11

Abstract

Human interferon alpha 2a (hIFNα2a) is a cytokine regulating immune system that has been used in hepatitis and cancer treatments. It has wide biological potency covering antiviral, antiproliferative and immunomodulative activities. This mini review discusses Roferon-A as a prominent commercial product of recombinant hIFNα2a which is produced in bacterial system, Escherichia coli, as therapeutic protein for several diseases, such as chronic viral Hepatitis B, Hepatitis C, melanoma, hairy cell leukemia and renal cell carcinoma. The discussion focuses on the development process with regard to its manufacturing, preclinical and clinical studies, as well as therapeutic efficacy. In addition, we also discuss biosimilar development of hIFNα2a and its potential future developments in the context of enhancing pharmacokinetic profiles
The Emergence of Biosimilars in Indonesia: Guidelines, Challenges and Prospects Andri Wardiana; Ratih Asmana Ningrum
ANNALES BOGORIENSES Vol 20, No 2 (2016): Annales Bogorienses
Publisher : Research Center for Biotechnology - Indonesian Institute of Sciences (LIPI)

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (259.258 KB) | DOI: 10.14203/ann.bogor.2016.v20.n2.37-46

Abstract

According to the Food and Drug Administration (FDA), biosimilar is defined as a product which is highly similar to the reference product without clinically meaningful differences in safety, purity and potency. Indonesia is a developing country which has more than 250 million people. The domestic need of Biosmilar in Indonesia is about 10-20%.  Even though the need is very high, Indonesia still has not been able to produce Biosimilar independently. To stimulate the domestic production on biosimilar, National Agency for Drug and Food Control (NADFC) Republic of Indonesia has assigned Regulation of Biosimilar as Peraturan Kepala Badan Pengawas Obat Dan Makanan Republik Indonesia Nomor 17 Tahun 2015 Tentang Pedoman Penilaian Produk Biosimilar. The guidance covers the quality requirement and evaluation of Biosimilar products. The Ministry of Health of Indonesia has a strategic plan in biopharmaceutical covering biosimilar which is going to develop in 2015-2025. The strategy is expected to initiate biosimilar production in Indonesia. This review focuses on the guidelines, challenges and prospects biosimilars in Indonesia comparing to other international regulatory bodies.Keywords: Biosimilar, Indonesia, Guidelines, Challenges and Prospects
Co-Authors Ratih Asmana Ningrum